Evidence map›Paper›PMID 37777976›Full record

ArticleEthics & human research

Ethics of Adaptive Designs for Randomized Controlled Trials.

Gershom Chongwe, Joseph Ali, Dan Kabonge Kaye, Charles Michelo, Nancy E Kass

Erratum issuedAbstract read
In one paragraph

Article in Ethics & human research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Gershom ChongweSenior lecturer in the Department of Epidemiology and Biostatistics at the University of Zambia School of Public Health and is also the director of the Tropical Diseases Research Centre.
Joseph AliAssociate professor in the Department of International Health at the Bloomberg School of Public Health and a core faculty member and the associate director for Global Programs at the Berman Institute of Bioethics at Johns Hopkins University.
Dan Kabonge KayeProfessor of obstetrics and gynecology and a lecturer in bioethics at Makerere University College of Health Sciences.
Charles MicheloProfessor of epidemiology and the founding dean for the School of Public Health at the University of Zambia, and he has transitioned to set up Nkwazi Research University, where he is the director for both the Global Health Institute and the Research Support Institute.
Nancy E KassPhoebe R. Berman Professor of Bioethics and Public Health at Johns Hopkins University, where she is also both the deputy director for public health in the Berman Institute of Bioethics and a professor of health policy and management in the Johns Hopkins Bloomberg School of Public Health.

Funding

Fogarty African Bioethics Post-Doctoral Training ProgramD43TW010512 · FIC · JOHNS HOPKINS UNIVERSITY · PI Joseph Ali, NANCY E KASS · 2017 to 2026
$2.2M
FIC NIH HHS D43 TW010512
6 · The paper itself

Abstract

Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

Indexed as

Ethics, ResearchResearch DesignAdaptive Clinical Trials as TopicHumansRandom AllocationRandomized Controlled Trials as TopicTherapeutic Equipoiseadaptive trialsautonomybeneficenceclinical equipoiserandomized controlled trialsRCTsresearch ethics

Identifiers

PMID37777976
PMCPMC10739783

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.